This invention relates to medical staples and stapling devices. More particularly, the invention relates to a staple in combination with a flexible, digitally manipulable, anvilless staple applicator that is useful for affixing catheters to the skin and for other medical procedures.
Medical stapling devices have been routinely in use for some time. They are designed chiefly to replace the suturing process because of the significantly less time used in stapling. A variety of devices are known. For example, Green, U.S. Pat. No. 5,158,567, describes an anvilless surgical stapler with articulated handles and a slidable staple cartridge mounted in a block at the distal end of the handles. Samuels, U.S. Pat. No. 4,399,810, describes a skin clip applied with an articulating device containing a substantial number of staples. The staples are closed by a lateral pressure from the articulating applier. U.S. Pat. Nos. 4,719,917 and 4,526,174 disclose other medical staples.
In surgical and anesthetic practice, it is common to place indwelling catheters for vascular access. These catheters require fixation to the skin to maintain their position, thus avoiding potential injury to the patient or withdrawal of the catheter. Currently, fixation to the skin is accomplished by suturing the catheter hub to the underlying skin. A needle and suture are passed through the skin and hub eye, or eyes, and tied into a knot.
This procedure includes an attendant risk of needle stick. To avoid that risk would require the use of a stapler kit, which is far too costly to justify its use for one or two staples. The use of a stapler would save considerable time over suturing, especially when considering the daily frequency of catheter fixations in clinical situations, but the cost of a stapler kit is orders of magnitude greater than that for a suturing kit.
The present invention allows fixation of catheters to the skin in a less time-consuming and safer manner than either suturing or the use of traditional medical staplers. The cost of the materials is anticipated to be, for practical purposes, approximately the equivalent of suturing.
The present invention is a method of stapling and a device for performing that method. The device comprises an applicator assembly, preferably made of sterilizable, medical grade plastic, and is disposable. A staple is fabricated from stainless steel or other commonly used FDA approved staple material, and is inserted into the applicator to form the assembly. The applicator has no anvil and is both flexible and digitally manipulable.
The staple includes a crown portion with legs obliquely positioned at the ends of the crown. The legs terminate in points capable of piercing the skin. In the preferred embodiments of the invention, a single staple is mounted in the applicator.
The applicator is shaped generally like an inverted xe2x80x9cU,xe2x80x9d with an open bottom to permit the exiting of a closed staple attached to the skin. The inner faces of the applicator include a stabilizing channel and grooves that retain the staple during both storage and application, and guide it during the application process. The outside faces of the two opposing arms of the applicator are preferably a relatively non-slip surface to facilitate a digital grasp of the applicator and to permit digital deformation of the applicator, which in turn deforms the staple.
In its preferred use, an applicator with staple is positioned to cause one of the two staple legs to traverse the catheter hub eye and both staple legs to pierce the skin when lateral forces are manually applied to the applicator arms. Closure of the staple then results in fixation of the catheter to the skin. The applicator can subsequently be slid off the staple, which is no longer held by the applicator due to the change in staple configuration relative to the released applicator.
In an alternate embodiment, two or more applicator and staple combinations are joined together to provide a device that can be used when two or more staples are necessary.
Accordingly, there are several objects and advantages to my invention. One advantage provides a means for securing a catheter to the skin using a surgical staple and applicator in a less time-consuming procedure than suturing.
Another advantage permits securing the catheter to the skin with less risk of needle stick injury when compared to the traditional method of suturing.
An object of the invention is to provide a stapler for affixing a catheter to the skin that is, relative to other staplers, less expensive to manufacture, easy to distribute and store in a clinical environment, and is both simple and reliable to use.
Still another object of the invention is to provide the availability of a small number of staples when the use of a traditional stapler kit is not economical.
These and other objects and advantages will become apparent in conjunction with the detailed description and the following drawings.